MAUDE Adverse Event Report: COVIDIEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030419
Medical Device Problem Codes	Misfire (2532); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that preoperatively, the reload was closed in the package when it was supposed to be open, and the staples were already released in the reload without the reload having been used.The device was replaced with another reload to fix the issue.There was no patient involved.Medtronic's initial evaluation of the incident found that the loading unit was partially fired.Staple pushers were observed between the 2cm and 1cm cut lines.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.A visual inspection of the returned photo noted one image of a reload.The jaws were clamped.Fully formed staples could be between the cartridge.Staple pushers could be seen up proximally.The i beam was advanced to the 2cm cut line.A loose fully formed staple could be seen.Visual inspection of the returned product noted that the jaws of the loading unit were clamped.Functional testing found that the loading unit jaws were manually opened.The loading unit was partially fired.Staple pushers were observed between the 2cm and 1cm cut lines.It was reported that the loading unit was partially fired.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the loading unit will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection, and prevent patient harm.The evaluation detected an unreported condition of incomplete retraction that is related to the reported condition.The product analysis noted evidence that the device was not used as intended.This issue can occur under the following conditions 1.The shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.2.The shipping wedge has been removed or is no longer fully seated in the metal channel and the jaws have been manually clamped prior to loading.3.The shipping wedge has been removed or is no longer fully seated in the metal channel and an attempt has been made to load a loading unit with the instrument firing rod extended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: in order to fire the instrument, push the green button.Squeeze the handle sequentially until the oval clamp cover reaches the distal end of the cartridge slot, and the handle locks.Sequential squeezes of the handle are required to fully fire the loading unit.The total number of squeezes is relative to the length of the loading unit (30, 45 or 60).Failure to completely fire the loading unit will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis.Please note that the yellow shipping wedge must be securely in place during instrument loading.The shipping wedge ensures that the sulu engages in the instrument to facilitate clamping and unclamping.Caution: do not attempt to remove the shipping wedge until the sulu is loaded into the instrument.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23842544
• Report Number: 2647580-2025-03793
• Device Sequence Number: 9835318
• Product Code: GDW
• UDI-Device Identifier: 10884523002966
• UDI-Public: (01)10884523002966(17)270131(10)P2B0061
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 030419
• Device Catalogue Number: 030419
• Device Lot Number: P2B0061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown